The aim of this study will be to assess the better fraction inspired oxygen (FiO2) threshold for the surfactant treatment in preterm infants with respiratory distress syndrome (RDS) randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. The pulmonary gas-exchanges will be evaluated by oxygen saturation (SpO2) to FiO2 ratio (SFR) and will be used to define the better FiO2 threshold for the surfactant treatment.
Exogenous surfactant therapy is an effective treatment of neonatal respiratory distress syndrome (RDS) and has been associated with reduced severity of respiratory distress and mortality. The 2019 European guidelines for neonatal RDS treatment suggest as the threshold of inspired oxygen (FiO2) for the surfactant treatment at 30% for all gestational age, but there are no randomized studies that confirm this indication. Some observational studies reported that a relevant number of patients who are not routinely treated with surfactant had respiratory complications, thus they received exogenous surfactant. To date, the optimal FiO2 threshold for surfactant administration remains unclear. In this single-center, randomized, phase 4 trial, preterm infants (gestational age\<32 weeks) with RDS will be randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. According to the unit policy, the exogenous surfactant will be administered by an endotracheal tube in intubated infants, or by Intubation-Surfactant-Extubation (InSurE) / Less Invasive Surfactant Administration (LISA) methods in infants who will not remain intubated. The method used for the surfactant administration will be at the discretion of the caring physician.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Exogenous surfactant (Poractant Alfa) administration at a dose of 200 mg/kg.
Respiratory pulmonary function
The oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2) ratio (SFR)
Time frame: At day 3 of life
Endotracheal intubation
The need of endotracheal intubation after surfactant administration
Time frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Oxygen therapy
The need of oxygen therapy
Time frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory Support-1
The need of respiratory support
Time frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory Support-1
Oxygenation index as indicator of the intensity of ventilatory
Time frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory severity-1
Silvermann score as secondary respiratory severity index
Time frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
Respiratory severity-2
Lung ultrasound score (LUS) score as secondary respiratory severity index
Time frame: At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first
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Long-term respiratory pulmonary function
The oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2) ratio (SFR)
Time frame: At day 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first, and 1 year of corrected age
Complications of prematurity
The incidence of intraventricular hemorrhage of grade 3-4, periventricular leukomalacia, bronchopulmonary dysplasia, sepsis and retinopathy of prematurity
Time frame: From birth to 36 weeks of postmenstrual age or discharge if it occurred first
In-hospital death
death before 36 weeks of gestation
Time frame: From birth to 36 week of gestation or discharge if it occurred first